Naloxegol in Cancer Opioid-Induced Constipation

Brief description of study

The purpose of this study is to compare the effect of naloxegol versus the patient's usual
care in treating opioid-induced constipation, as well as the effect on the patient's quality
of life and how much pain is experienced. Also, the purpose of this study is to compare
whether treatment with naloxegol versus usual care has any impact on the number of hospital
or clinic visits or telephone calls to the patient's physician that are related to
constipation, and to determine the patient's preference for continuing to receive naloxegol
as treatment for opioid-induced constipation.

Detailed Study Description

Opioid-induced constipation (OIC) is a common symptom in patients with cancer-related pain
and requires burdensome self-titration of laxatives for prophylaxis and treatment.
Consequently, naloxegol may have an important role in this setting. Naloxegol has been
evaluated in relieving OIC with cancer patients in a randomized, double blind,
placebo-controlled trial over 4 weeks with a 12-week extension phase. However, accrual was
challenging and the trial was closed early. Given the complexity of cancer and its treatment,
a key first step is to determine if evaluating naloxegol versus standard of care is feasible
in the management of OIC in this setting.

Subjects will receive naloxegol 25mg daily or usual care for a 2-week initial treatment
period followed by 3-day washout period, then a 2-week crossover treatment period where
subjects will receive naloxegol or usual care. Treatment assignment during the initial and
crossover treatment periods will be dictated by the randomization arm. Subjects will also
have the option to participate in a 12-week extension phase of naloxegol.